Pharmaceutical manufacturing entails a diversity of intricate processes that involve the use of numerous chemicals and substances. While the industry stands as one of the most significant contributors to global health, it also presents grave chemical risks. These hazards, when not appropriately managed, can harm workers, the environment, consumers, and the manufacturer's reputation. 

Whether you have an in-house environmental safety team or decide to work with safety consultant services, understanding these chemical risks, identifying their potential impacts, and implementing effective management strategies is an integral aspect of pharmaceutical manufacturing.

Pharmaceutical Manufacturing Risks

Chemical exposure can cause both acute and chronic effects which can occur immediately or after years have passed. The risk to human health is reflected in the standards set by the Resource Conservation and Recovery Act, OSHA, and the Environmental Protection Agency (EPA). 

The chemical risks within pharmaceutical manufacturing are broad, ranging from fire and explosion hazards to harmful exposure to hazardous substances. Some of the most prominent risks include:

Human Health Risks

The primary concern is that chemical exposure (and entry into the body) can cause health problems for humans. The five main forms of human exposure include: 

Inhalation 

Hazardous chemicals in the air may be inhaled and may cause damage to the body. 

Skin contact 

Some hazardous chemicals may damage the skin directly or may be absorbed into the body through the skin. 

Eye contact 

Contact with some hazardous chemicals may cause serious eye injuries. 

Ingestion 

Hazardous chemical products may enter the body while eating or drinking food contaminated by chemicals. 

Injection 

Sharp objects can puncture the skin and inject chemicals or viruses into the body. 

Environmental Health Risks

Chemical exposure can also create risks for the environment. Specifically, it can impact both the natural and built environments. 

If the natural environment is exposed to chemicals through improper disposal of waste or through some other type of leak, the repercussions can be severe causing significant air, soil, and water pollution. Hazardous chemicals also have the potential to cause damage to built infrastructure through corrosion, combustion, contamination, and more. 

Risk Management 

In order to protect all stakeholders involved in pharmaceutical manufacturing, it’s critical to undertake risk assessment. The information obtained in a risk assessment provides a basis for better addressing the chemical risks and hazards as well as when and where they may happen so that a site can be properly designed for safe operation. 

One key safety measure that is at the center of design and process planning is occupational exposure limits (OELs). OELs are the maximum concentrations of chemicals in the air of a workspace, and an important metric for OELs is the amount of highly potent APIs (HPAPIs). HPAPI refers to compounds that elicit a biological response at a very low dose. Traditional examples of HPAPIs are cytotoxic compounds and sex hormones such as estrogen. However, any type of compound can be highly potent if it causes a response at a low dose.

Nonetheless, HPAPIs will be critical to manage to meet OELs set by regulatory offices. When discussing OELs for pharmaceutical manufacturing, some common terminology to know includes: 

Level of action 

An airborne level, typically half the permissible exposure limits designated in the OSHA substance-specific standards, that triggers the implementation of certain activities such as exposure monitoring and medical surveillance. 

Ceiling limit 

The limit that a worker’s exposure may never exceed. 

Sampling and analytical error 

A statistical estimate of the uncertainty associated with a given exposure measurement. 

Short-term exposure limit (STEL) 

The average exposure to a contaminant to which a worker can be exposed for a short period of time (typically 15–30 minutes). 

Time-weighted average (TWA) 

Average exposure to a pollutant in a given period of time, typically 8 hours. 

Assessment of Pharmaceutical Risk Areas

In pharmaceutical manufacturing, there are several key physical spaces that, should there be a breach of safety, could pose serious chemical risks. Therefore, it’s important to design a unique safety process for each of those spaces. 

Manufacturing Areas: The location where the physical manufacturing takes place often poses some of the highest risks. 

Research and Development: Laboratories where research, development, and testing occur are a high risk due to the number of chemicals present. 

Storage Infrastructure: Finished pharmaceutical products and the materials, substances, solvents, and reagents they are made of need proper storage for safety. 

Enlisting the Help of Safety Consultant Services

The presence of inherent chemical risks in pharmaceutical manufacturing underscores the need to implement safety programs and protocols that will safeguard your employees, customers, and the environment. 

At The SP Group, we offer fundamental support in identifying and managing chemical risks through risk assessments, employee training programs, compliance audits, and emergency response strategies. Get in touch with our team today to see how we can help with all your environmental health and safety consulting needs!